Status:
COMPLETED
Assess Safety & Reactogenicity of GSK Biologicals' Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b Disease
Eligibility:
All Genders
3-4 years
Phase:
PHASE4
Brief Summary
To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 mont...
Detailed Description
All subjects will be randomized into two groups. One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone. A specific follow-up of solicited local...
Eligibility Criteria
Inclusion
- A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
Exclusion
- Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
- Chronic administration of immunosuppressants or other immune-modifying drugs from birth until administration of first dose of study vaccine.
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT00158795
Start Date
January 1 2005
End Date
July 1 2005
Last Update
May 30 2017
Active Locations (1)
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1
GSK Investigational Site
Nanning, Guangxi, China, 530021